STRATEGIC FUTURE
(FY 1999-2004)

The Animal Drugs and Feeds Program's performance goals will support the Agency's overall strategies as follows:

The Animal Drugs and Feeds Program strategic goal is to increase the availability and diversity of safe and effective products that relieve animal pain and suffering, sustain their health, improve animal productivity, and do not compromise public health.

In order to increase the availability and diversity of safe and effective products, the Animal Drugs and Feeds Program will expedite and facilitate the approval of new animal drugs by implementing the Animal Drug Availability Act of 1996 (ADAA) [1] and our reinventing government (REGO) initiative. The Animal Drugs and Feeds Program will inform and assist product sponsors throughout the approval process starting with the Pre-submission Conference. Focus will be on informing and assisting firms in complying with the new legislation and streamlining the product review process by continuing the implementation of the phased review process. Streamlining efforts will be focused on reducing the overall time required for drug development from product conception by the drug sponsor through the Investigational New Animal Drug phase to the New Animal Drug approval. New performance measures will be developed to assess progress toward our goals. Better automated information systems, including those supporting electronic submission of applications by sponsors, will be developed to facilitate and expedite the review process.

In order to enable the marketing of effective animal drugs and food additives, the Animal Drugs and Feeds Program will take regulatory actions to remove unapproved drugs and food additives from the market. The Animal Drugs and Feeds Program will also ensure that approved products provide for safe human food products derived from animals as well as ensure quality health care of animals. The surveillance plans will enhance the ability of FDA to monitor adverse reactions to veterinary products and to detect animal and public health risks such as drug residues in meat, eggs or milk. Partnerships with other government agencies, state and local government, and regulated industry as well as expanded educational programs will enable the Animal Drugs and Feeds Program to maintain the current level of compliance.

Assumptions: The FY 1999 performance goals are contingent on the Food Safety Initiative. It is also assumed that USDA will continue to support their national sampling plan and forward violations to FDA. The target levels of the performance goals are based on the assumption that there will be no additional streamlining decreases.

STRATEGIC GOAL AREA: PREMARKET REVIEW

FY 1999 Performance Goal Highlights Implement the Animal Drug Availability Act including the Veterinary Feed Directive (VFD). Begin automating the review process. Increase risk assessment for anti-microbial products by 10%.

Cluster Rationale: Safe and effective veterinary drugs are essential for improved production of food-producing animals, as well as for the health and well-being of both companion and food producing animals. Improved production of food-producing animals has a positive economic effect on the agricultural community which increases the availability of animal products for human consumption. The New Animal Drug Review is part of the approval process and supports the overall mission of both FDA and the United States Department of Agriculture to ensure that animal-derived products are safe for human consumption. In support of the safety determination for edible products from food producing animals, risk assessment is becoming an important aspect of the approval process. The Animal Drugs and Feeds Program, through the New Animal Drug Review process, works toward the increased availability of new animal drugs.

The New Animal Drug Review Process is a natural cluster because it groups the pre-approval activities of the Animal Drugs and Feeds Program. It includes goals related to the implementation of the Animal Drug Availability Act (ADAA) which inform and assist product sponsors as well as goals related to new processes that have been developed to streamline the approval process under FDA's three reinventing government (REGO) initiatives. It also includes goals related to risk assessments and antimicrobial products as part of the pre-approval food safety evaluation.

The immediate outcome from these performance goals will be a decrease in the developmental time and costs associated with research studies and other drug approval regulatory requirements. Pre-submission conferences and availability of the Center for Veterinary Medicine (CVM) guidelines through the Internet (CVM Home Page) and workshops will increase industry efficiency and thereby reduce overall developmental costs. Phased review will provide more timely feedback as well as "early detection" of application deficiencies.

The streamlined processes will decrease overall review time and thereby increase the availability of safe and effective animal drugs. Phased review, coupled with improved information systems such as electronic submission of applications, will allow FDA to perform review activities more efficiently. This will enable the agricultural community to provide animal-derived products more effectively and possibly at a lower cost due to the reduced animal drug developmental costs being reflected in lower costs to purchasers.

A third immediate outcome is increased availability of drugs to treat companion animals, thereby increasing their life span and the quality of life. Studies have shown that companion animals have a positive effect on the quality of life of selected segments of the human population. Companion animals are used to increase independence of individuals with disabilities such as guide dogs for the blind, working dogs for the deaf, and a variety of animals assisting physically-challenged individuals.

A primary ultimate outcome is safe animal products for human consumption. Veterinarians and the agricultural community need animal drugs to ensure a safe food supply. New drugs are needed as disease causing agents mutate and become resistant to current drugs. Risk assessment related to antimicrobial products contributes to risk management decisions and availability of safe and effective animal drugs. Human consumption of safe animal products contributes to a balanced diet, which contributes to better health.

This cluster supports the Agency's premarket review goal area, specifically the strategies of informing and assisting product sponsors and streamlining reviews. Information dissemination is critical to the successful implementation of the ADAA and our REGO initiatives and the development of a collaborative atmosphere which benefits drug sponsors, FDA reviewers, taxpayers, and the general public.

Resources, Approaches, Processes, Skills, and Technology: Resources are primarily devoted to new animal drug review, but also include surveillance activities in the field and research that supports the review process.

A sponsor notifies CVM about the development of a new animal drug. CVM works with the sponsor to set up a pre-submission conference. The conference can be conducted "in-person" or by teleconference, or in the future, by video conference. Information exchange continues throughout the research and development process. As the sponsor completes a technical section (the different pieces of a New Animal Drug Application), it is submitted to CVM for review. The technical sections include target animal safety and effectiveness, manufacturing methods and control chemistry, residue chemistry and regulatory methods, human food safety, and environmental safety.

Routine postmarket surveillance activities and special surveys are conducted to assure that sponsors are in compliance with regulations intended to ensure data integrity and good manufacturing practices. Pre-approval inspections are conducted when needed, to enhance understanding and confirm that the sponsor has the ability to produce a safe and effective product.

Research is an essential element in the approval process. Method validation studies are necessary in approving applications for new drugs for food animals. In addition to methods validation, analytical methods development research improves the effectiveness of surveillance activities by providing more rapid and accurate procedures to detect and quantitate chemical substances in foods. Information system development improves the ability of primary reviewers to access Agency and sponsor data used in the review process.

New Animal Drug Review activities are supported by scientific research, data collection, and analysis. Scientists provide guidance and assistance to industry, consumers, and other constituencies regarding regulatory interpretations related to animal drugs and feeds. They also serve as national experts by providing technical expertise for the development and harmonization of international specifications and standards in the area of veterinary medicine.

STRATEGIC GOAL AREA: POSTMARKET ASSURANCE

FY 1999 Performance Goal Highlights Assure that the domestic animal drug and feed manufacturing establishments inspected by FDA achieve a 90% rate of conformance with FDA requirements. Improve monitoring of antibiotic resistant bacteria. Implement BSE regulations.

Cluster Rationale: The Postmarket Assurance Process is a natural cluster because it groups the postmarket activities of the Animal Drugs and Feeds Program. Through improving/enhancing our compliance strategy FDA will reduce the availability of unsafe animal drugs. Through the use of the National Surveillance System, we will monitor current patterns and take action to contain antimicrobial resistance. Through development of partnership relationships with industry and the states, we will implement the ADAA through new regulations, development of educational initiatives, and, as needed, the development of enforcement strategies to assure public safety.

The immediate outcome will be the on-going establishment and updating of baseline data to:

1. establish standards which will be used to evaluate the compliance of marketed products;
2. identify emerging patterns of antibiotic resistance; and
3. direct resources toward high risk product areas.

The ultimate outcome is the assurance that marketed animal drugs and food additives provide for safe food products derived from animals and ensure quality health care of animals. Postmarket surveillance is an important aspect of assuring continual safe animal products for human consumption.

This cluster supports the Agency's postmarket assurance goal area, specifically the strategies to develop science-based product and process standards, improve surveillance and follow-up on adverse events, maintain inspection visibility, and inform and assist firms to achieve compliance.

Resources, Approaches, Processes, Skills, And Technology: Resources are primarily devoted to monitoring and surveillance activities, including FDA field inspections/investigations, data review and analysis, educational initiatives, scientific research, and development of compliance and enforcement strategies.

FDA is notified about potential postmarket problems via one or more of its early warning systems. FDA reviews National Surveillance System data, Adverse Drug Reports (ADRs), Establishment Inspection Reports (EIRs), Contamination Response System (CRS) data, Residue Violation Information System (RVIS), or other forms of communication. FDA then takes the appropriate action to address emerging issues, prevent or contain problems, and bring the animal drug industry into compliance.

Routine postmarket surveillance activities and special surveys are conducted to assure that sponsors are in compliance with regulations designated to ensure data integrity and good manufacturing practices. In FY 1999, FDA will continue activities initiated in FY 1998 to ensure that industry complies with the regulations to protect animals from transmissible degenerative neurological diseases, and to minimize any potential risk that such diseases could be transmitted from animals to humans.

In addition, FDA partners with other Federal and state agencies, our stakeholders, and regulated industry to develop and sponsor workshops, symposia, and publications with a focus on prevention in order to assure the public that accurate information is disseminated and that marketed animal drugs and feeds are safe and effective. Collaborative investigational contracts to identify farm management practices will also contribute to the FDA's effort to reduce the occurrence of foodborne disease.

Research is an essential element in postmarket assurance. Research studies are necessary in order to develop methods for detecting drugs and drug residues that may be present in food products derived from animals. In addition to methods development, analytical methods development research improves the effectiveness of monitoring for antibiotic resistance patterns and provides more rapid and accurate procedures to detect and quantify chemical substances in foods.

Strategic Goal Area:	PREMARKET REVIEW
Cluster:	New Animal Drug Review
1. Improve application processing by implementing ADAA legislation and CVM REGO initiatives, including the Veterinary Feed Directive (VFD),by establishing and/or revising regulations and guidance documents.
Agency Strategies:	Inform and assist product sponsors.
Data Sources:	CVM's priority project tracking system.
Baseline Data:	Due to new legislative approach, application processing baselines are not yet available, but will be reestablished in FY 1998 - FY 1999.
2. Improve application processing time by implementing electronic submission for key components of the investigational new animal drug application process.
Agency Strategies:	Streamline reviews.
Data Sources:	CVM's priority project tracking system.
Baseline Data:	Due to new legislative approach, application processing baselines are not yet available, but will be reestablished in FY 1998 - FY 1999.
3. Increase the number of antimicrobial product risk assessments by 10% in order to increase the assurance that food derived from animals and animal products is safe for human consumption.
Agency Strategies:	Streamline reviews.
Data Sources:	CVM's priority project tracking system.
Baseline Data:	Risk assessment baselines will be established in FY 1998.

Strategic Goal Area:	POSTMARKET ASSURANCE
Cluster:	Postmarket Assurance
1. Assure that FDA inspections of domestic animal drug and feed manufacturing establishments, in conjunction with the timely corrections of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year.
Agency Strategies:	Inform and assist firms to achieve compliance.
Data Sources:	Field Data Systems.
Baseline Data:	Prior compliance performance measures have been essentially counts of activities at various points along the enforcement continuum - i.e., number of inspections, violative inspections, warning letters, prosecutions, etc. This new measure strives to integrate the results of these activities into an end-of -the year statement about the compliance status of this specific industry sector. A prototype of the new measure will be generated in FY 1998.
2. Assure that food derived from animals and animal products is safe for human consumption by increasing the number of human and animal isolates in the National Antimicrobial Monitoring Program database.
Agency Strategies:	Improve surveillance and follow-up on adverse events.
Data Sources:	FDA-CDC-USDA National Antimicrobial Monitoring Program.
Baseline Data:	FY 1996: 1000 Human Isolates, 1000 Animal Isolates.
3. Protect public health (human) and animal health by ensuring compliance with good manufacturing practices including the newly implemented BSE (Mad Cow Disease) regulation through education, regulatory inspections and industry/Federal/state partnerships.
Agency Strategies:	Inform and assist firms to achieve compliance.
Data Sources:	Field Information System.
Baseline Data:	To be developed in FY 1998.

1. ADAA substantially alters the way FDA regulates and approves animal drugs and medicated feeds by granting the authority to exercise considerable flexibility in regulatory decision making. During the implementation phase, which includes promulgation of regulations through notice and comment rulemaking, FDA is continuing the dialogue with stakeholders that began prior to the passage of the ADAA.